DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic renal cell carcinoma with measurable disease. Tumor tissue available and properly stored for lysate preparation. Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects. Karnofsky Performance Status ≥60% Life expectancy ≥ twelve weeks Adequate end organ function: Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl Liver: AST < 2 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN, serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome) Renal: serum creatinine < 2.0 x ULN. Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age. Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, or serious cardiac arrhythmias. Patients over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia. CNS: No history of brain metastases. Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study. Appropriate Contraception in both sexes EXCLUSION CRITERIA: Patients may have not have been treated previously with IL-2, IFNα or autologous vaccine. Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS. In patients with a prior history of invasive malignancy, less than five years in complete remission Positive serology for HIV, hepatitis B or hepatitis C, Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen. Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 4 weeks must have passed since the last dose). History of autoimmune disease.
Sites / Locations
- Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Arms of the Study
Arm 1
Experimental
Vaccine, Aldesleukin-2, Interferon-a
All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.